PeriodontitisNCT00990041
Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects
An observational study of Periodontitis, run by Escola Bahiana de Medicina e Saude Publica at 1 site in Brazil.
Trial summary
Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy humans
Who may be able to join
- periodontitis
Who cannot join
- diabetes
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia de Piracicaba
Piracicaba, São Paulo, 13000
About this study
Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. Thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by PBMC.
Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the smokers and non-smokers of each group were separately evaluated: SP- smokers with severe generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP- non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.
- Conditions
- Periodontitis
- Keywords
- periodontitis, find cytokines in blood of periodontal patients
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PBMC | Not described | |
| periodontitis | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Escola Bahiana de Medicina e Saude Publica
- Sponsor type
- University, hospital or other
- Collaborators
- School of Odontology of Piracicaba - Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990041
- Sponsor's protocol ID
- 9002-10-04.PBMC
- Status last verified
- Oct 2009
- First submitted
- 5 Oct 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects
- ClinicalTrials.gov ID
- NCT00990041
- Acronym / sponsor ID
- 9002-10-04.PBMC
- Conditions
- Periodontitis
- Keywords
- periodontitis, find cytokines in blood of periodontal patients
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Escola Bahiana de Medicina e Saude PublicaUniversity, hospital or other
- Collaborators
- School of Odontology of Piracicaba - Unicamp
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. Thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by PBMC.
Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the smokers and non-smokers of each group were separately evaluated: SP- smokers with severe generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP- non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBMC | – | – |
| periodontitis | – | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy humans
Key inclusion criteria (1 listed)
- periodontitis
Key exclusion criteria (1 listed)
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Escola Bahiana de Medicina e Saude Publica at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2009.